The Effect of Oral Magnesium Supplementation on Vascular Calcification in Chronic Kidney Disease - A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 6
- 主要终点
- Coronary Artery Calcification (CAC) score
研究概览
简要总结
Randomized placebo-controlled double-blinded interventional trial to investigate the effect of oral magnesium supplementation on vascular calcification in subjects with chronic kidney disease. We hypothesize that oral magnesium supplementation will reduce vascular calcification in subjects with chronic kidney disease while not decreasing bone mineral density.
详细描述
Chronic kidney disease (CKD) is associated with increase cardiovascular morbidity and mortality independent of traditional cardiovascular risk factors due to increased vascular calcification. Epidemiological and experimental data suggest that hypermagnesemia and magnesium supplementation reduce vascular calcification in CKD by increasing calcium/phosphate solubility in serum, by inhibiting calcium influx into vascular smooth muscle cells (VSMC), by inhibiting intracellular pro-calcification enzymes in VSMC and by increasing activity of intracellular anti-calcification enzymes in VSMC. However, there have been concerns that any anti-calcification effect of magnesium might also reduce bone mineral density, in which case there might be an increased risk of bone fractures associated with magnesium supplementation in CKD. We wish to conduct a randomized placebo-controlled double-blinded interventional trial to examine whether oral magnesium supplementation will reduce vascular calcification in subjects with CKD while not decreasing bone mineral density.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated glomerular filtration rate between 45 and 15 mL/min for > 3 months (i.e. CKD stage 3b-4).
- •Serum total magnesium < 0,82 mmol/L and serum phosphate > 1,15 mmol/L on average of previous measurements.
- •or Serum total magnesium < 0,92 mmol/L and serum phosphate > 1,30 mmol/L on average of previous measurements.
- •Life expectancy > 1 year.
- •Expected time until initiation of dialysis or transplantation > 1 year.
- •Women of childbearing age must be actively using contraceptive therapy (p-pills, estrogen depots or intrauterine device) as well as have a negative pregnancy test.
- •Written informed consent.
排除标准
- •Current hemodialysis or peritoneal dialysis treatment.
- •Kidney donor recipient.
- •Previous coronary artery bypass graft (CABG).
- •Parathyroid hormone > 600 ρmol/L.
- •Previous parathyroidectomy.
- •Current treatment with magnesium containing medication or supplements.
- •Any condition impairing magnesium absorption from the gastrointestinal tract (e.g. short bowel syndrome, chronic pancreatitis).
- •Active malignancy (basal or squamous cell skin carcinoma, localized prostate cancer and cancer with no signs of reoccurrence after 5 years are exempt from this).
- •Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of trial.
- •Pregnancy or breastfeeding.
- •Allergy towards contents of interventional medication.
- •Participation in other interventional trials.
结局指标
主要结局
Coronary Artery Calcification (CAC) score
时间窗: 12 months
Agatston score assessed by CT scan.
次要结局
- Serum Calcification Propensity(12 months.)
- Pulse Wave Velocity(12 months.)
- Bone Mineral Density (BMD)(12 months)